Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department

Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial

Migraine is a chronic and sometimes progressive disorder, characterized by headache, recurrent episodes, and other associated symptoms. Migraine is the most common cause of headache among patients who applied to emergency services.

The purpose of the investigators is to compare the efficacy of oral paracetamol and zolmitriptan in the treatment of acute migraine headache in an emergency department.

Study Overview

• Status: Completed
• Conditions: Acute Migraine Headache
• Intervention / Treatment: Drug: Paracetamol; Drug: Zolmitriptan

Detailed Description

• This is prospective, randomized, controlled research to compare the efficacy of these two drugs in emergancy department.
• The clinical trial was conducted in the ED of Pamukkale University Medical Faculty Hospital.
• Study personnel (emergency physicians and nurses) were trained before the study.
• When oral drugs (paracetamol, zolmitriptan was being recommended, an eligibility checklist was completed by the attending physician.
• If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial headache pain score ratings with VAS and NRS were recorded.
• The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
• All patients eligible for the study were randomized to one of two groups:
• First Group: paracetamol 1000 mg was given oral to 100 patients,
• Second Group: Zolmitriptan 2,5 mg was given oral to 100 patients which determined to be applied as a group.
• Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations.
• The allocation list was kept by the emergency nurse. Patients received the paracetamol, zolmitriptan medication schemes according to their random allocations.
• After enrollment and recording of baseline information, the next numbered study drug was obtained, and administered as oral.
• Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
• One researcher blinded to patient allocation observed the whole procedure and recorded the Headache scores.
• Headache scores were recorded at 0, 15, 30, and 60 min on a VAS of 1 to 100 mm and NRS of 1 to 10. Patients with nausea are treated with 15 minutes of 10 mg metoclorpramide slow infusion in 150 cc saline solution.
• Rescue medication (1 mcg/kg fentanyl ) was given İntravenöz to patients if pain VAS scores ≥ 50 mm in 60 minutes after study drug administration.
• All other medications required during the study also were recorded.
• During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20070
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
• Had acute migraine attack without aura
• VAS (visual analog scale) score >50 mm , NRS (Numeric Rating Scale) score >5
• Patients whose written consent is obtained by agreeing to participate in the study

Exclusion Criteria:

• Those who refuse to participate in the work
• Patients younger than 18 years or older than 65 years
• Those who use ergotamine derivative drugs in the last 24 hours
• Have received analgesics in the last 6 hours
• Patients with severe liver, kidney, lung and heart failure
• To have active peptic ulcer bleeding or perforation
• Have a history of upper gastrointestinal disease
• To be Pregnancy and breast-feeding
• Patients of childbearing age who are not using a birth control method.
• Allergy to medicines used in work
• Hemodynamically unstable patients
• Patients with renal transplantation
• Blood pressure uncontrolled hypertension patients
• Patients with cerebrovascular disease history
• Patients with ischemic heart disease or coronary spasm / printzmetal angina
• Patients with arrhythmia accompanying Wolff-Parkinson-White syndrome or accessory conduits in the heart
• Patients with Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency
• Those with other systemic diseases,
• Patients with a Visual Analogue Scale (VAS) pain score less than 50 mm
• Illiterates and patients with vision problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracetamol; 1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients	Drug: Paracetamol; 1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients; Other Names: Parol
Experimental: Zolmitriptan; Second Group: Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients.	Drug: Zolmitriptan; Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients; Other Names: Zomig

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrement of the pain on VAS	1. Compare decrease of migraine headache VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)	Change from baseline in migraine headache VAS score at 60 minutes
Decrement of the pain on NRS	1. Compare decrease of migraine headache NRS (Numeric Rating Scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)	Change from baseline in migraine headache NRS score at 60 minutes

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Cuneyt Arikan, MD, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Migraine; Paracetamol; Zolmitriptan; Emergency services
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Disease Attributes; Headache Disorders, Primary; Headache Disorders; Emergencies; Migraine Disorders; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Acetaminophen; Zolmitriptan
• Other Study ID Numbers: 2015TPF039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No